The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also help to reduce radiation-induced fatigue in brain tumor patients.

Taken orally once a day in the morning. Dose will change depending upon level of fatigue

Other Name: Nuvigil

Placebo Comparator: Group 2

Placebo

Other: Placebo

Placebo taken once a day in the morning

Detailed Description:

Since no one knows for certain if armodafinil improves fatigue in brain tumor patients undergoing radiation therapy, participants will be randomized into one of two study groups. Half of the participants will receive armodafinil and the other half will receive pills with no medicine (placebo). Neither the participant or the study doctor will know what group they are in.

Participants will be given a study medication-dosing calendar and will take either the study drug or placebo orally once a day for 8 weeks. The dose will be adjusted on days 8,22 or 43, depending upon the level of fatigue. Treatment will begin within 10 days from the radiation start date.

Participants will be evaluated via documented clinician telephone call and self-administered questionnaires on days 1, 8, 22, 43 and 57.

Has taken a psychostimulant or a monoamine oxidase inhibitor on a regular basis within the past 30 days

Clinically significant untreated sleep apnea

A history of clinically significant cardiac disease, including a history of recent myocardial infarction, history of unstable angina, history of left ventricular hypertrophy, or a history of ischemic ECG changes, chest pain, arrhythmia, or other clinically significant manifestations of mitral valve prolapse in association with use of CNS stimulants (e.g. caffeine, amphetamines, methylphenidate)

Patients taking warfarin for anticoagulation are eligible, but monitoring of prothrombin times is suggested as a precaution

Hemoglobin level of less then 11 g/dl

Laboratory evidence of hypothyroidism with an elevated TSH concentration in the blood greater than 5.0 mlU/L

Current treatment or history of psychotic disorder, bipolar disorder, or anxiety disorder

Patients with a score of > 28 on the Beck depression inventory consistent with severe depression

Known hypersensitivity to armodafinil or related compounds

Patients who have been receiving MAO inhibitors during the past 14 days

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766467